The Supreme Court of the United States (SCOTUS) has issued a ruling that reduces the liability of pharmaceutical companies because the medication that they produce has already been approved by the FDA while also being parented by other companies. In other words, they cannot be sued for defect in drug design.
This trial was brought to the Supreme Court due to a prior case where Karen Bartlett had an adverse reaction to sulindac, prescription anti-inflammatory medication, which was made by Merck.
The patient developed this reaction described as Stevens-Johnson syndrome or toxic epidermal necrolysis to the medication that was prescribed to her for shoulder pain in 2004. In three weeks, she had lost 60% of the surface layer of her skin while suffering from permanent vision loss.
Even though she had been awarded $21 million by a New Hampshire federal jury, the case was then moved to the Supreme Court by Mutual Pharmaceuticals, where the prior ruling of $21 million was overturned in favor of the aforementioned pharmaceutical company.
Since the FDA had approved the drug, and federal laws have authority over state laws, the Obama administration were in support of Mutual Pharmaceuticals.
This has been an important alternate outcome of this case, where when regulations conflict between state and federal laws, the latter prevails. This sometimes leaves pharmaceutical companies in the lurch as they are not able to satisfy both state or federal regulations.
It’s unfortunate that Bartlett cannot take any further action and which led Sotomayor to express her unhappiness in not being able to provide a remedy to a seriously injured customer.
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